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Comparison the effect of education based on the theory of planned behavior and video based education on the knowledge, attitude, and breastfeeding performance of mothers of premature infants hospitalized in the neonatal intensive care unit

Protocol summary

Study aim
Comparison the effect of education based on the theory of planned behavior and video based education on the knowledge, attitude, and breastfeeding performance of mothers of premature infants hospitalized in the neonatal intensive care unit
Design
A clinical trial with intervention and control groups, single-blinded, using convenience sampling, conducted on 58 patients. The sample size was determined using G*Power software.
Settings and conduct
This clinical trial was conducted in the NICU of Shahid Sadoughi Hospital, Yazd. Fifty-eight eligible mothers of preterm infants were non-randomly selected and allocated into two groups (29 each) using a single-blind method. Both groups completed the baseline questionnaires. The intervention group then received TPB-based breastfeeding education, whereas the control group received standard video education. Post-test data were collected by having all participants complete the same questionnaires two weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers of premature infants hospitalized in the NICU, Iranian nationality, basic literacy, no substance abuse, medically stable; premature infants hospitalized in NICU with sucking ability and no need for gavage feeding. Exclusion criteria: Mothers with breastfeeding contraindications, concurrent participation in other studies; infants unable to receive breast milk, infants with cardiac anomalies and various syndromes.
Intervention groups
Intervention group: Mothers of preterm infants hospitalized in the NICU who received breastfeeding education based on the Theory of Planned Behavior. Control group: Mothers of preterm infants hospitalized in the NICU who received routine breastfeeding video education.
Main outcome variables
Breastfeeding knowledge, attitude, and practice scores

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251117068027N1
Registration date: 2026-02-26, 1404/12/07
Registration timing: prospective

Last update: 2026-02-26, 1404/12/07
Update count: 0
Registration date
2026-02-26, 1404/12/07
Registrant information
Name
maryam babaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4434 0516
Email address
m.babaee@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-14, 1404/12/23
Expected recruitment end date
2026-07-14, 1405/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of education based on the theory of planned behavior and video based education on the knowledge, attitude, and breastfeeding performance of mothers of premature infants hospitalized in the neonatal intensive care unit
Public title
Comparison the effect of theory-based education versus video-based education on breastfeeding
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers of premature infants hospitalized in the NICU. Iranian nationality. Having at least basic literacy (reading and writing). No maternal addiction to alcohol or cigarettes. Medically stable and able to attend the sessions. Premature infants hospitalized in the NICU, possessing the ability to suck and not requiring gavage feeding.
Exclusion criteria:
Mothers with contraindications for breastfeeding, such as having AIDS/HIV or active tuberculosis. Mothers who use medications that are prohibited during breastfeeding. Mothers who are simultaneously participating in another study related to breastfeeding while enrolled in our study Infants who are unable to receive breast milk due to medical conditions or anomalies such as cleft palate Infants with cardiac anomalies and various syndromes.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor blinding: This is the most important form of blinding feasible in this design. The person who collects the questionnaires after the intervention and the person who enters and analyzes the data in SPSS software must not know which group (test or control) each participant was in. This prevents biased interpretation of the results.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Nursing and Midwifery School, Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Bouali Street, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2025-11-11, 1404/08/20
Ethics committee reference number
IR.SSU.REC.1404.134

Health conditions studied

1

Description of health condition studied
Breastfeeding in premature neonates
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breastfeeding knowledge score
Timepoint
before the intervention and two weeks after the intervention.
Method of measurement
Breastfeeding Knowledge scale

2

Description
Breastfeeding attitude score
Timepoint
before the intervention and two weeks after the intervention.
Method of measurement
Theory of Planned Behavior scale

3

Description
Breastfeeding Performance score
Timepoint
before the intervention and two weeks after the intervention.
Method of measurement
Breastfeeding Performance scale

Secondary outcomes

1

Description
Perceived Behavioral Control Score
Timepoint
before the intervention and two weeks after the intervention.
Method of measurement
Theory of Planned Behavior scale

2

Description
Subjective Norms Score
Timepoint
before the intervention and two weeks after the intervention.
Method of measurement
Theory of Planned Behavior scale

3

Description
Behavioral Intention Score
Timepoint
before the intervention and two weeks after the intervention.
Method of measurement
Theory of Planned Behavior scale

Intervention groups

1

Description
Intervention group: Mothers of preterm infants hospitalized in the NICU who received breastfeeding education based on the Theory of Planned Behavior. The educational intervention will consist of 4 training sessions, each lasting 60 to 90 minutes. These sessions will be conducted over 4 days during the week (Saturday to Tuesday). The sessions will be held in small groups, with 4 or 5 mothers participating together with the instructor.
Category
Other

2

Description
Control group: Video-based training on breastfeeding will be delivered to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Maryam Babaee
Street address
Ibn Sina Boulevard, Shahid Ghandi Boulevard, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4100
Fax
+98 35 3822 4100
Email
maryambabaee.nurse@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mehran Karimi
Street address
Central Administration Building, Shahid Sadoughi University of Medical Sciences, Baharan Square
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 913 358 4608
Email
sh.bolandian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Bolandian Bafghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bouali Street, Yazd.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 917 258 9636
Email
sh.bolandian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Bolandian Bafghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bouali Street, Yazd.
City
Yazd
Province
Fars
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 917 258 9636
Email
sh.bolandian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Bolandian Bafghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bouali Street, Yazd, Iran.
City
yazd
Province
Fars
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 917 258 9636
Email
sh.bolandian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The raw data files of the demographic information, Theory of Planned Behavior, knowledge, and breastfeeding practice scale are shareable.
When the data will become available and for how long
Access period begins in 2025.
To whom data/document is available
Researchers affiliated with academic and scientific institutions.
Under which criteria data/document could be used
The use of the scales in research projects is permitted.
From where data/document is obtainable
To receive the scales, please send a message to the email address: sh.bolandian@yahoo.com
What processes are involved for a request to access data/document
To receive the scales, please send a message to the email address: sh.bolandian@yahoo.com
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